Test Catalog

Test Id : CENO

Cenobamate, Serum

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring serum concentrations of cenobamate to optimize efficacy and minimize toxicity

Method Name
A short description of the method used to perform the test

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Cenobamate, S

Aliases
Lists additional common names for a test, as an aid in searching

Xcopri

Ontozry

Specimen Type
Describes the specimen type validated for testing

Serum Red

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Red top (serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 1.2 mL Serum

Collection Instructions: Within 2 hours of collection, centrifuge, and aliquot serum into a plastic vial.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

Serum: 0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Red Refrigerated (preferred) 28 days
Ambient 28 days
Frozen 28 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring serum concentrations of cenobamate to optimize efficacy and minimize toxicity

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Cenobamate was approved by the US Food and Drug Administration for the treatment of partial-onset seizures in adult patients. Cenobamate reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents and is a positive allosteric modulator of the gamma-aminobutyric acid (GABA-A) ion channel.

 

Common side effects may include double vision (diplopia), dizziness, somnolence, fatigue, or headache. Severe effects include QT interval shortening and acute hepatic failure.

 

Cenobamate has good oral bioavailability (88%) is extensively metabolized and primarily eliminated through the renal system (approximately 6% unchanged) with a long elimination half-life (50-60 hours).

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Trough concentrations of 5 to 35 mcg/mL for daily dosages of 100 to 400 mg/day

Interpretation
Provides information to assist in interpretation of the test results

Ninety-five percent of patients with 50% seizure reduction or seizure freedom had trough serum cenobamate concentrations between 5 mcg/mL and 35 mcg/mL when taking 100 to 400 mg/day.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

No significant cautionary statements

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Greene SA, Kamin M. Cenobamate Trough Plasma Concentrations in Patients With Uncontrolled Focal Seizures Achieving 50% and 100% Seizure Reduction in Two Randomized Clinical Studies (1377). Neurology 2021;96(15_supplement):1377

2. Krauss GL, Klein P, Brandt C, et al. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2020;19(1):38-48. doi:10.1016/S1474-4422(19)30399-0

3. Roberti R, De Caro C, Iannone LF, Zaccara G, Lattanzi S, Russo E. Pharmacology of Cenobamate: Mechanism of Action, Pharmacokinetics, Drug-Drug Interactions and Tolerability. CNS Drugs. 2021;35(6):609-618. doi:10.1007/s40263-021-00819-8

4. Wheless JW. Adjunctive cenobamate for the treatment of focal onset seizures in adults with epilepsy: a critical review. Expert Rev Neurother. 2020;20(11):1085-1098. doi:10.1080/14737175.2020.1834855

5. Steinhoff BJ, Georgiou D, Dietmann D, Intravooth T. Cenobamate plasma levels in patients with epilepsy: correlation with efficacy and tolerability?. J Clin Med. 2024;13(10):2757. doi:10.3390/jcm13102757

6. Johannessen Landmark C, Belkilani H, Awad L, et al. Pharmacokinetic variability and complex two-way interactions with cenobamate in patients with refractory epilepsy. Epilepsia. 2026;67(6):2820-2835. doi:10.1002/epi.70184

7. Elliott T, Ridley-Pryor T, Gienapp AJ, Wheless JW. Initial real-world experience with cenobamate in adolescents and adults: A single center experience. Pediatr Neurol. 2022;129:19-23. doi:10.1016/j.pediatrneurol.2022.01.001

8. Beltran-Corbellini A, Romeral-Jimenez M, Mayo P, et al. Cenobamate in patients with highly refractory focal epilepsy: A retrospective real-world study. Seizure. 2023;111:71-77. doi:10.1016/j.seizure.2023.07.026

9. Smith MC, Klein P, Krauss GL, et al. Dose Adjustment of Concomitant Antiseizure Medications During Cenobamate Treatment: Expert Opinion Consensus Recommendations. Neurol Ther. 2022;11(4):1705-1720. doi:10.1007/s40120-022-00400-5

Method Description
Describes how the test is performed and provides a method-specific reference

The sample is diluted with an acetonitrile internal standard. The protein precipitate is centrifuged, and a portion of the supernatant is diluted for detection by a tandem mass spectrometry.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Mayo Clinic Laboratories - Rochester Superior Drive
CLIA Number: 24D1040592

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80299

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CENO Cenobamate, S 96909-7
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
624174 Cenobamate, S 96909-7

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

No Sample Reports Available